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The Effects of Medical Clowning on Blood Pressure and Pulse Rate of Patients Undergoing Cataract Surgery Under Local Anesthesia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by HaEmek Medical Center, Israel.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00806832
First received: December 9, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

Cataract surgery is the most prevalent surgical procedure. Since most candidates are elderly patients, hypertension is common among these patients. Preoperative anxiety and tension may cause elevation of patient's heart rate and blood pressure and thus expose them to serious potential complications such as stroke and myocardial infarction. Medical clowns are known to reduce preoperative anxiety of both children and their parents. It is possible therefore that medical clown may have such a beneficial effect also on patients scheduled for cataract surgery under local anesthesia.


Condition
Blood Pressure
Heart Rate

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Effects of Medical Clowning on Blood Pressure and Pulse Rate of Patients Undergoing Cataract Surgery Under Local Anesthesia

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Cataract
U.S. FDA Resources

Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • Blood pressure [ Time Frame: day of surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • heart rate [ Time Frame: day of surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: December 2008
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Medical clowns treatment
Patients scheduled for an elective cataract surgery will receive pre-operative conventional treatment and in addition will be exposed to medical clowns effect
Conventional treatment only
Patients scheduled for elective cataract surgery will receive only conventional pre-operative treatment

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The study population will include patients from the town of Afula and its surrounding region who are scheduled for cataract surgery in Ha'Emek Medical Center.

Criteria

Inclusion Criteria:

  • Patients undergoing an elective, ambulatory cataract surgery (phacoemulsification technique)
  • Surgery planned to be performed under local anesthesia
  • Age > 40 years
  • Patients signed an informed consent

Exclusion Criteria:

  • Hypertensive patients who did not take their prescribed medications on the day of surgery
  • Uncontrolled hypertension during the month preceding the surgery
  • Patients with systolic and diastolic BP values of >190 and 100 mmHg respectively, measured 1hr prior to surgery
  • Patients not suitable for surgery under local anesthesia
  • Patients in whom the planned phacoemulsification technique was converted to either the ECCE or ICCE technique
  • Patients in whom an anterior vitrectomy had to be performed during surgery
  • Patients treated regularly by anti-anxiety or analgetic treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00806832

Contacts
Contact: Yaron Lang, MD 972-54-4449060 ylang@012.net.il

Locations
Israel
Department of Ophthalmology, Ha'Emek MC Recruiting
Afula, Israel, 18101
Contact: Yaron Lang, MD     972-54-4449060     ylang@012.net.il    
Principal Investigator: Yaron Lang, MD            
Sub-Investigator: Oded Vafsi, MD            
Sub-Investigator: Wasim Hilu, MD            
Sub-Investigator: Rachel Shier            
Sub-Investigator: Dan Meiron, MD            
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: Yaron Lang, MD Dept. of Ophthalmology, Ha'Emek MC, Afula, Israel
  More Information

Publications:

Responsible Party: Yaron Lang, MD, Department of Ophthalmology, HaEmek MC, Afula, Israel
ClinicalTrials.gov Identifier: NCT00806832     History of Changes
Other Study ID Numbers: 0087-08-EMC
Study First Received: December 9, 2008
Last Updated: December 9, 2008
Health Authority: Israel: Ethics Commission

Keywords provided by HaEmek Medical Center, Israel:
Medical clowns
Cataract surgery
Blood pressure
Heart rate

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013